Programmed Death-1 (PD-1) Antibody Combined With Chemoradiotherapy in High-risk Recurrent Nasopharyngeal Carcinoma

NCT03930498 | Active Not Recruiting Phase 2

• 1 other identifier: High-risk rNPC-JS001
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

This is a a prospective, single-arm phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemotherapy in high-risk recurrent nasopharyngeal carcinoma.

Conditions

Recurrent Nasopharyngeal Carcinoma

Keywords

PD-1 antibody; Intensity-modulated Radiation Therapy; Chemotherapy; Efficacy; Adverse effects

Outcome Measures

Primary Outcomes (1)

• Overall survival

  From date of recruitment to death

  2 years

Secondary Outcomes (5)

• Objective response rate

  After 3 cycles of GP chemothrapy plus PD-1 antibody (each cycle is 21 days)

• Disease control rate

  After 3 cycles of GP chemothrapy plus PD-1 antibody (each cycle is 21 days)

• Progression free survival

  2 years

• Adverse effects

  through study completion, an average of 3 months

• Quality of life: EuroQoL 5 dimension

  through whole study, an average of 2 years

Study Arms (1)

PD-1 antibody plus chemoradiotherapy

EXPERIMENTAL

Drug: PD-1 blocking antibody; Drug: Chemotherapy; Radiation: IMRT

Interventions

PD-1 blocking antibody DRUG

Toripalimab is an antibody targeting PD-1 developed by Shanghai Junshi Biosciences Co., Ltd.

Also known as: JS001

PD-1 antibody plus chemoradiotherapy

Chemotherapy DRUG

Cisplatin and Gemcitabine

PD-1 antibody plus chemoradiotherapy

IMRT RADIATION

IMRT 60-66Gy, 1.8-2.0Gy/f/day

PD-1 antibody plus chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed as local recurrence ± regional recurrence after ≥1 year of radical treatment;
• Not suitable for surgery;
• Newly histologic diagnosis of NPC (WHO II/III);
• Clinical stage rII-IVa (AJCC/UICC 8th);
• ECOG 0-1 point;
• PRANCIS score \> 252 points;
• No treatment to rNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
• No contraindications to immunotherapy or chemoradiotherapy;
• Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;
• Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;
• Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
• Take effective contraceptions during and two months after treatment;
• Patients must be informed of the investigational nature of this study and give written informed consent.

You may not qualify if:

• Have recurrence with local necrosis;
• Have ≥G3 late toxicities, except for skin, subcutaneous tissue or mucosa;
• Unexplained fever \> 38.5 ℃, except for tumor fever;
• Treated with ≥ 5 days antibiotics one month before enrollment;
• Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy);
• Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E3copiers/ml) or hepatitis C virus (HCV) antibody positive;
• Have previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway;
• Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment;
• Have known allergy to large molecule protein products or any compound of study therapy;
• Pregnant or breastfeeding;
• Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;
• Have received a live vaccine within 30 days of planned start of study therapy Has psychiatric drug or substance abuse disorders that would interfere with cooperation with the requirements of the trial;
• Any other condition, including mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Links

• Home Page of Sun Yat-sen University Cancer Center

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Chong Zhao, M.D

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: April 29, 2019
• Study Start: March 12, 2020
• Primary Completion: November 22, 2023
• Study Completion: December 1, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)